Planet Pharma
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http://www.theplanetgroup.com
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Sr. Manager, Site Contracts and Budgets
200 Tech Square Cambridge, MA 02142 US
Posted: 05/18/2023
2023-05-18
2023-07-07
Employment Type:
Contract
Job Category: Clinical Development and Operations
Job Number: 565997
Is job remote?: No
Country: United States
Job Description
(Target PR: 60-104/hr)
*Depending on experience
The Role:
Reporting to the Sr. Director, Clinical Site Management and Monitoring (CSMM) the Senior (Sr.) Manager, Site Contracts and Budgets is responsible for program and/or clinical trial-level management and oversight of site contract and budget negotiation and execution for Phase I-IV clinical trials. The Sr. Manager will collaborate closely with key CDO functional stakeholders, including CSMM, Clinical Trial Excellence and Support (CTES) and Clinical Operations in the development and ongoing oversight of site contracts and budgets execution during the clinical trial start up (SSU) phase to support site activation as per target timelines.
Here’s What You’ll Do:
Responsible for direct oversight and management of site contracts and budgets for multiple assigned clinical trials within designated therapeutic area.
Provide consistent site contract/budgets oversight and support to assigned Clinical Operations clinical trial teams, offering up-front and ongoing strategic planning specific to the program and needs of individual studies.
Leverage use of internal and CRO provided Investigator Grants (IG) reference data and available Fair Market Value (FMV) benchmarking tools to establish clinical trial-specific IG budget estimates for trial budget forecasting needs.
Lead and/or contribute to development of target FMV-based IG budget and negotiation parameters according to therapeutic area (infectious disease, oncology and/or therapeutics) in an outsourced CRO model.
Act as lead point of contact (POC) for CRO site contracts and budgets-related activities for assigned studies; oversee the development and approval of global investigator site budgets and associated negotiation parameters. Ensure cross-program/cross-clinical trial consistency in country-level site budget targets and parameters.
Responsible for direct management and tracking of CRO investigator site CTA/budget negotiations in alignment with FMV and GCP-driven principles.
Collaborate with assigned CRO and Clinical Operations in ensuring that established clinical trial IG budget remains within target during CTA negotiations process
Serve as liaison between CRO and Legal/Clinical Contracts and Outsourcing teams in the review and finalization of country-level CTAs/CSA templates.
Monitor KPIs, including cycle times and SIV/site activation targets, to ensure adherence to baseline clinical trial timelines for CTA negotiation and site activation.
Attend Clinical Trial Team (CTT) and/or joint client/CRO clinical trial team meetings on an agenda-driven basis, i.e. when strategic decisions that impact site contracts are being discussed.
Act as lead POC for required site contract and/or budget amendments throughout the duration of assigned studies.
Proactively identifies site contract-related risks and potential roadblocks.
Escalates issues proactively to Sr. Director, CSMM and/or Clinical Operations teams to prevent delays in site activation timelines.
Here’s What You’ll Bring to the Table:
Minimum 5 years’ direct experience in global investigator site budget negotiations; preferable experience in CTA template language negotiations and/or support in collaboration with Legal.
Effective communication and collaboration with key internal and external stakeholders, including CDO, CRO and investigator site personnel.
Familiarity in working within an outsourced model; experience in direct CRO oversight of CTA/budget negotiations.
Strong experience in use of various site contract and budget management systems, processes, and computer software (e.g., Grants Manager, Grant Plan)
Proficient in MS Office Products with advanced knowledge of Excel; ability to work with and be proficient in stand-alone system applications.
High level of attention to detail in management of high volumes of investigator site financial data.
Works on increasingly complex and problems of diverse scope requiring critical analysis and comprehensive evaluation of critical factors.
Increasingly exercising independent judgment in developing methods and techniques to obtain solutions (and process improvements).
Increasing independence in determining specific tasks to accomplish in order to meet certain goals and objectives.
Increasing self-reliance in performing tasks.
Works in a team environment.
*Depending on experience
The Role:
Reporting to the Sr. Director, Clinical Site Management and Monitoring (CSMM) the Senior (Sr.) Manager, Site Contracts and Budgets is responsible for program and/or clinical trial-level management and oversight of site contract and budget negotiation and execution for Phase I-IV clinical trials. The Sr. Manager will collaborate closely with key CDO functional stakeholders, including CSMM, Clinical Trial Excellence and Support (CTES) and Clinical Operations in the development and ongoing oversight of site contracts and budgets execution during the clinical trial start up (SSU) phase to support site activation as per target timelines.
Here’s What You’ll Do:
Responsible for direct oversight and management of site contracts and budgets for multiple assigned clinical trials within designated therapeutic area.
Provide consistent site contract/budgets oversight and support to assigned Clinical Operations clinical trial teams, offering up-front and ongoing strategic planning specific to the program and needs of individual studies.
Leverage use of internal and CRO provided Investigator Grants (IG) reference data and available Fair Market Value (FMV) benchmarking tools to establish clinical trial-specific IG budget estimates for trial budget forecasting needs.
Lead and/or contribute to development of target FMV-based IG budget and negotiation parameters according to therapeutic area (infectious disease, oncology and/or therapeutics) in an outsourced CRO model.
Act as lead point of contact (POC) for CRO site contracts and budgets-related activities for assigned studies; oversee the development and approval of global investigator site budgets and associated negotiation parameters. Ensure cross-program/cross-clinical trial consistency in country-level site budget targets and parameters.
Responsible for direct management and tracking of CRO investigator site CTA/budget negotiations in alignment with FMV and GCP-driven principles.
Collaborate with assigned CRO and Clinical Operations in ensuring that established clinical trial IG budget remains within target during CTA negotiations process
Serve as liaison between CRO and Legal/Clinical Contracts and Outsourcing teams in the review and finalization of country-level CTAs/CSA templates.
Monitor KPIs, including cycle times and SIV/site activation targets, to ensure adherence to baseline clinical trial timelines for CTA negotiation and site activation.
Attend Clinical Trial Team (CTT) and/or joint client/CRO clinical trial team meetings on an agenda-driven basis, i.e. when strategic decisions that impact site contracts are being discussed.
Act as lead POC for required site contract and/or budget amendments throughout the duration of assigned studies.
Proactively identifies site contract-related risks and potential roadblocks.
Escalates issues proactively to Sr. Director, CSMM and/or Clinical Operations teams to prevent delays in site activation timelines.
Here’s What You’ll Bring to the Table:
Minimum 5 years’ direct experience in global investigator site budget negotiations; preferable experience in CTA template language negotiations and/or support in collaboration with Legal.
Effective communication and collaboration with key internal and external stakeholders, including CDO, CRO and investigator site personnel.
Familiarity in working within an outsourced model; experience in direct CRO oversight of CTA/budget negotiations.
Strong experience in use of various site contract and budget management systems, processes, and computer software (e.g., Grants Manager, Grant Plan)
Proficient in MS Office Products with advanced knowledge of Excel; ability to work with and be proficient in stand-alone system applications.
High level of attention to detail in management of high volumes of investigator site financial data.
Works on increasingly complex and problems of diverse scope requiring critical analysis and comprehensive evaluation of critical factors.
Increasingly exercising independent judgment in developing methods and techniques to obtain solutions (and process improvements).
Increasing independence in determining specific tasks to accomplish in order to meet certain goals and objectives.
Increasing self-reliance in performing tasks.
Works in a team environment.
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